Edwards Lifesciences Principal Engineer, Human Factors -Advanced Technology in Irvine, California
This is a unique opportunity to foster and support human factors and usability engineering activities with new product development and commercial teams across projects and business units. This is a high visibility and high impact career opportunity.
Support patient-first corporate strategy by applying knowledge of human factors engineering requirements and best practices to minimize use-related risk and achieve device and system clinical success.
Apply knowledge of device users and use environments and engineering knowledge to the design and development of new products and product changes.
Engage and influence business unit and project team leadership to support human factors and usability engineering activities throughout the product development process.
Partner with clinical, quality, regulatory, marketing, and R&D functions from multiple project teams to promote and execute best practices in human factors and usability engineering, identify and mitigate use-related risks, and ensure compliance with internal requirements and external regulations and expectations.
Support planning and executing usability research and evaluations.
Initiate and perform analytical usability assessments of devices and systems.
Document results of usability evaluations and other usability engineering process deliverables, including usability engineering plans, protocols, reports, team debriefs, design reviews, etc.
Identify opportunities to improve product usability by engaging with clinicians and other device users to collect user feedback (both objective and subjective) on devices.
Provide creative solutions to alleviate complex usability problems.
Maintain current knowledge of human factors and usability regulations, expectations, and best practices.
Some domestic and international travel (up to 5%).
Bachelor’s degree with 8 years’ experience OR a Master's degree with 7 years’ experience OR a PhD with 4 years’ experience.
Suitable undergraduate and/or graduate degrees include human factors engineering, industrial design, mechanical engineering, biomedical engineering, or a related engineering/science discipline.
Experience in the medical device or other highly regulated industry is required.
Human factors / usability engineering experience is required.
Experience planning and executing human factors studies utilizing various methodologies such as ethnographic research, contextual inquiry, cognitive walk through, heuristic analysis, task analysis, simulated use studies, and summative testing.
Ability to draw conclusions and make recommendations based on technical inputs from multiple and varied sources. Ability to be collaborative and flexible in approach to solving user interface related challenges.
Effective communication, listening, and diagnostic skills are required to interface with health care professionals and team members from various departments.
Ability to clearly communicate how study results can be implemented into design, including analyzing and synthesizing large quantities of information into usable content for project teams and the business
Must be proactive and creative in solving technical problems.
Strong documentation and organizational skills
Must be a dynamic team player and a highly motivated self-starter able to achieve results independently and through cross-functional collaboration.
Demonstrated ability to present to and interact with senior leadership.
Clinical experience with medical implantable devices is highly desirable.
UI/UX design experience is highly desirable.
Industrial design experience is a plus.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all patient-facing and in-hospitals positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who enter a hospital or healthcare facility as part of their role. If hired and your position meets this criteria, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19 or have a valid religious or medical exemption from being vaccinated.
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.